SODIUM CHLORIDE Recall D-0177-2023
Description: 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.
SODIUM CHLORIDE Recall D-0177-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0177-2023 |
| Event ID | 91449 |
| Brand | SODIUM CHLORIDE |
| Generic Name | SODIUM CHLORIDE |
| Manufacturer | SODIUM CHLORIDE |
| Original Package? | 1 |
| Active Substance | SODIUM CHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 378 bags |
| Recall Reason | CGMP Deviations: potential for trace amounts of product carryover. |
| Drug Classification | Class II |
| Drug Code Info | 20230201 |
| Product NDC | 0487-4301 |
| Drug UPC | 0000000000000 304874301103 |
| Recall Initiation Date | 20230112 |
| Report Date | 20230201 |
| Classification Date | 20230124 |
| Address | 4500 12th Street Ext West Columbia, SC 29172-3025 United States |
| Recalling Firm | Nephron Sc Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 451W47IQ8X |
| Drug Application Number | ANDA211968 |
| Structured Product Labeling (SPL ID) | c3e073a5-e0e4-c908-e053-2a95a90a0bd0 |
| Structured Product Labeling (SPL Set ID) | a4edf2d5-a9ff-30d4-e053-2995a90a5650 |
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